Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02388737
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2015-03-09
Brief Title:
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Double-Dummy Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a comparative study of vonoprazan TAK-438 10 mg or 20 mg in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor PPI to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment 6 months or 24 weeks as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis
Detailed Description:
The drug being tested in this study is called vonoprazan Vonoprazan is being tested as a maintenance treatment for people with healed erosive esophagitis EE This study will look at participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor PPI to demonstrate the non-inferiority of vonoprazan to Lansoprazole in their maintenance treatment 6 months or 24 weeks as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis
The study will enroll approximately 693 patients Participants will be randomly assigned by chance like flipping a coin to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
TAK-438 10 mg
TAK-438 20 mg
Lansoprazole 15 mg
Participants with ongoing erosive esophagitis EE will receive lansoprazole 30 mg once daily for 4 or 8 weeks the Healing phase until healing of EE is confirmed by endoscopy performed at either Week -4 andor Day 1 before eligible for randomization to maintenance phase In Maintenance phase participants with confirming EE healing will be asked to take 2 tablets and a capsule at the same time each morning after breakfast throughout the study All participants will be asked to record daytime and nighttime during sleep subjective symptoms in a diary on a daily basis
This multi-centre trial will be conducted worldwide The overall time to participate in this study is 8 months Participants will make multiple visits to the clinic and will be contacted by telephone 7-14 days after last dose of study drug for a follow-up assessment
The study will enroll approximately 693 patients Participants will be randomly assigned by chance like flipping a coin to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
TAK-438 10 mg
TAK-438 20 mg
Lansoprazole 15 mg
Participants with ongoing erosive esophagitis EE will receive lansoprazole 30 mg once daily for 4 or 8 weeks the Healing phase until healing of EE is confirmed by endoscopy performed at either Week -4 andor Day 1 before eligible for randomization to maintenance phase In Maintenance phase participants with confirming EE healing will be asked to take 2 tablets and a capsule at the same time each morning after breakfast throughout the study All participants will be asked to record daytime and nighttime during sleep subjective symptoms in a diary on a daily basis
This multi-centre trial will be conducted worldwide The overall time to participate in this study is 8 months Participants will make multiple visits to the clinic and will be contacted by telephone 7-14 days after last dose of study drug for a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20150039 | REGISTRY | SFDA CTR | None |
| U1111-1136-5706 | REGISTRY | None | None |